Supplemental biologics licence application submitted for daratumumab

Genmab’s licensing partner, Janssen Biotech, has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in front line multiple myeloma.

This new licence specifically relates to use of daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

“We are extremely pleased that submissions have now been made in both the US and Europe for daratumumab to treat patients with newly diagnosed multiple myeloma,” said Jan van de Winkel, PhD, chief executive officer of Genmab. “We believe these submissions exemplify the further potential of daratumumab, and we look forward to working with both Janssen and the FDA to bring DARZALEX to a wider group of multiple myeloma patients.”

Genmab granted an exclusive worldwide licence to Janssen in August 2012 for the development, manufacture and commercialisation of daratumumab. Janssen has submitted a priority review for this sBLA to the FDA, which will inform Janssen of whether it is granted priority review or not within 60 days. If granted, then the review should be completed within six months.

Additionally, Janssen has submitted a Type II variation application for daratumumab in this indication to the European Medicines Agency (EMA).